Dolutegravir sodium - Generic Drug Details

What are the generic drug sources for dolutegravir sodium and what is the scope of freedom to operate?

Dolutegravir sodium is the generic ingredient in four branded drugs marketed by Viiv Hlthcare and is included in four NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dolutegravir sodium has one hundred and fifty-five patent family members in thirty-five countries.

There are seventeen drug master file entries for dolutegravir sodium. Three suppliers are listed for this compound. There are eight tentative approvals for this compound.

Summary for dolutegravir sodium

International Patents:	155
US Patents:	6
Tradenames:	4
Applicants:	1
NDAs:	4
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	1
Patent Applications:	96
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dolutegravir sodium
What excipients (inactive ingredients) are in dolutegravir sodium?	dolutegravir sodium excipients list
DailyMed Link:	dolutegravir sodium at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for dolutegravir sodium

Constraining patent/regulatory exclusivity:

9,242,986*PED

Dosage:

TABLET, FOR SUSPENSION;ORAL

Constraining patent/regulatory exclusivity:

9,242,986*PED

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for dolutegravir sodium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
St Stephens Aids Trust	Phase 4

See all dolutegravir sodium clinical trials

Generic filers with tentative approvals for DOLUTEGRAVIR SODIUM

Applicant	Application No.	Strength	Dosage Form
		50MG	TABLET;ORAL
		50MG	TABLET;ORAL
		50MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for dolutegravir sodium

Drug Class	Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Mechanism of Action	HIV Integrase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Organic Cation Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for dolutegravir sodium

J05AJ	Integrase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for DOLUTEGRAVIR SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TIVICAY PD	Tablets for Suspension	dolutegravir sodium	5 mg	213983	1	2021-07-21
TIVICAY	Tablets	dolutegravir sodium	10 mg, 25 mg and 50 mg	204790	4	2017-08-14

US Patents and Regulatory Information for dolutegravir sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes	8,129,385*PED				Y
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-002	Jun 9, 2016		DISCN	Yes	No	8,129,385*PED				Y
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-001	Aug 12, 2013		RX	Yes	Yes	9,242,986*PED				Y
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes	9,242,986*PED				Y
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes	10,426,780		Y	Y
Viiv Hlthcare	TIVICAY PD	dolutegravir sodium	TABLET, FOR SUSPENSION;ORAL	213983-001	Jun 12, 2020		RX	Yes	Yes	8,129,385*PED				Y

International Patents for dolutegravir sodium

Country	Patent Number	Title	Estimated Expiration
Israel	225207	נגזרת של קרבאמוילפירידון רב-טבעתי, הרכב רוקחי המכיל אותה, השימוש בה ותהליך להכנתה (Polycyclic carbamoylpyridone derivative, pharmaceutical composition comprising the same, use and process for preparation thereof)
World Intellectual Property Organization (WIPO)	2006088173
Norway	20161315	Polysyklisk karbamoylpyridonderivat som har integrase inhibitorisk aktivitet
Canada	2606282	DERIVE POLYCYCLIQUE DE LA CARBAMOYLPYRIDONE A ACTIVITE INHIBITRICE SUR L'INTEGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASEINHIBITORY ACTIVITY)
European Patent Office	3187225	DÉRIVÉ DE CARBAMOYLPYRIDONE POLYCYCLIQUE DOTÉ D'UNE ACTIVITÉ INHIBITRICE DE L'INTÉGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY)
Hungary	S1400039

Supplementary Protection Certificates for dolutegravir sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	2014/032	Ireland		PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
2465580	SPC/GB21/030	United Kingdom		PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221
2932970	C201830054	Spain		PRODUCT NAME: COMBINACION QUE COMPRENDE DOLUTEGRAVIR O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO (DOLUTEGRAVIR SODICO) Y RILPIVIRINA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA (RILPIVIRINA HIDROCLORURO); NATIONAL AUTHORISATION NUMBER: EU/1/18/1282; DATE OF AUTHORISATION: 20180516; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1282; DATE OF FIRST AUTHORISATION IN EEA: 20180516
2932970	122018000125	Germany		PRODUCT NAME: EINE KOMBINATION UMFASSEND DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON (Z. B DOLUTEGRAVIR NATRIUM) UND RILPIVIRIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON (Z.B RILPIVIRIN HYDROCHLORID); REGISTRATION NO/DATE: EU/1/18/1282 20180516
2465580	2021/013	Ireland		PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/20/1481 20201221
2932970	CA 2018 00036	Denmark		PRODUCT NAME: KOMBINATION OMFATTENDE DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, F.EKS. DOLUTEGRAVIRNATRIUM, OG RILPIVIRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, F.EKS. RILPIVIRINHYDROCHLORID; REG. NO/DATE: EU/1/18/1282/001-002 20180518

Dolutegravir sodium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dolutegravir Sodium

Introduction to Dolutegravir Sodium

Dolutegravir sodium, a potent antiretroviral drug, has been a cornerstone in the treatment of HIV/AIDS due to its exceptional efficacy in inhibiting HIV replication and its favorable safety profile. Here, we delve into the market dynamics and financial trajectory of this crucial medication.

Market Size and Growth Projections

The global Dolutegravir market has shown significant growth and is expected to continue this trend. As of 2023, the market size was valued at USD 5.2 billion and is projected to reach USD 9.99 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5% from 2024 to 2031[1].

Geographical Distribution

The market for Dolutegravir is segmented geographically into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America stands out as a prominent consumer of Dolutegravir, driven by advanced healthcare infrastructure and high awareness of antiretroviral therapies[3].

Key Drivers of the Market

Several factors are driving the growth of the Dolutegravir market:

Efficacy and Safety Profile

Dolutegravir's effectiveness in treating HIV/AIDS, combined with its favorable safety profile, has led to its widespread incorporation into treatment regimens globally[1].

Increasing HIV Incidence

The rising number of HIV diagnoses, particularly in regions with high prevalence rates, has created a growing need for efficient treatment options like Dolutegravir[1].

Access Initiatives

Efforts by non-governmental and governmental organizations to increase access to antiretroviral medicines in low- and middle-income countries have significantly boosted the market[1].

Innovative Formulations

Partnerships between academic institutions and pharmaceutical companies have spurred innovation, leading to the development of new formulations and combination medications that further propel market expansion[1].

Market Dynamics: Drivers, Restraints, Opportunities, and Challenges

Drivers

• Government and NGO Support: Initiatives to increase access to antiretroviral drugs in underserved regions.
• Research and Development: Ongoing research into new applications, such as use in juvenile populations and combination therapies.
• Economic Factors: Growing healthcare expenditure and increasing awareness of HIV treatment options[1].

Restraints

• Cost and Affordability: High costs associated with Dolutegravir, particularly in low-income countries.
• Regulatory Hurdles: Stringent regulatory requirements that can slow down market entry and expansion.
• Side Effects: Although rare, side effects can impact patient compliance and market growth[1].

Opportunities

• Emerging Markets: Growing demand in Asia-Pacific and other emerging regions.
• Combination Therapies: Potential for Dolutegravir to be used in combination with other antiretroviral drugs.
• Pediatric Use: Research into its use in juvenile populations offers new market opportunities[1].

Challenges

• Generic Competition: Potential entry of generic versions that could reduce market share of branded products.
• Resistance and Side Effects: The risk of drug resistance and side effects that could impact long-term use[1].

Competitive Landscape

The competitive landscape of the Dolutegravir market is characterized by several major players, including ViiV Healthcare (GSK), Shanghai Desano Pharmaceuticals, Mylan, Aurobindo Pharma, LAURUS Labs, and Adcock Ingram Limited. These companies are engaged in continuous innovation, product benchmarking, and strategic partnerships to maintain their market position[1].

Financial Performance and Projections

The financial performance of the Dolutegravir market is robust, with significant revenue growth anticipated. Here are some key financial metrics:

• Market Size: USD 5.2 billion in 2023, expected to reach USD 9.99 billion by 2031[1].
• CAGR: 5% from 2024 to 2031[1].
• Volume: Approximately 20 thousand tonnes in 2023, growing at a CAGR of 4.9% until 2034[3].

Price Trends and Fluctuations

Price trends for Dolutegravir have shown fluctuations, particularly in the North American market. In the final quarter of 2023, prices experienced noticeable downward trends, indicating market dynamics and competitive pressures[4].

Innovative Formulations and Research

Research into new formulations, such as nanoemulsions, is ongoing. For instance, a recent study focused on the development and evaluation of Dolutegravir sodium nanoemulsion using the high-shear homogenization method, which could enhance bioavailability and patient compliance[2].

Conclusion

The market for Dolutegravir sodium is poised for continued growth driven by its efficacy, increasing demand, and innovative formulations. Despite challenges such as cost and regulatory hurdles, the market is expected to expand significantly over the next decade.

Key Takeaways

• Market Growth: Expected to reach USD 9.99 billion by 2031.
• Key Drivers: Efficacy, increasing HIV incidence, access initiatives, and innovative formulations.
• Competitive Landscape: Dominated by major players like ViiV Healthcare (GSK) and others.
• Financial Performance: Robust growth with a CAGR of 5% from 2024 to 2031.
• Innovative Formulations: Ongoing research into new delivery methods like nanoemulsions.

Frequently Asked Questions

Q1: What is the current market size of Dolutegravir in terms of value?

• The global Dolutegravir market was valued at USD 5.2 billion in 2023[1].

Q2: Which region is the largest consumer of Dolutegravir?

• North America is the prominent consumer of Dolutegravir globally[3].

Q3: What is the expected CAGR of the Dolutegravir market from 2024 to 2031?

• The market is expected to grow at a CAGR of 5% from 2024 to 2031[1].

Q4: What are the key factors driving the growth of the Dolutegravir market?

• Efficacy, increasing HIV incidence, access initiatives, and innovative formulations are key drivers[1].

Q5: Are there any ongoing research and development activities for Dolutegravir?

• Yes, ongoing research includes the development of new formulations like nanoemulsions and potential use in juvenile populations[2].

Cited Sources

1. Market Research Intellect - Dolutegravir Market Size, Trends and Projections
2. ResearchGate - Formulation and Evaluation of Dolutegravir Sodium Nanoemulsion for the Treatment of HIV
3. ChemAnalyst - Dolutegravir Market Size, Share, Growth and Forecast to 2034
4. ChemAnalyst - Dolutegravir Prices, News, Monitor, Analysis & Demand